FDA fully approves Pfizer COVID-19 vaccine

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Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” 

Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.

FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.

Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into – nor does it alter – an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”

FDA Evaluation of Safety and Effectiveness Data for Approval for 16 Years of Age and Older

The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals.

To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.

Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.

Based on results from the clinical trial, the Pfizer vaccine was 91% effective in preventing COVID-19 disease.

More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.

The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.

Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.

Ongoing Safety Monitoring

The FDA and Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner. In addition, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.

The FDA granted this application Priority Review. The approval was granted to BioNTech Manufacturing GmbH.

Related Information

Health department announces changes COVID-19 vaccination schedule changes

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GAINESVILLE – Several District 2 Public Health Departments are adjusting their Covid-19 vaccination schedules. This will allow the county health departments to continue vaccinations and expand hours for other health department services.

Changes to vaccination schedules – start date, location, and days for vaccination:

Union County

Will move to the health department, 67 Chase Dr., Blairsville, on April 26. This week vaccinations will be available Monday to Friday. However, beginning on May 4, vaccinations will be available on Tuesday, Wednesday, and Thursday only. Walk-ins will be accepted from 10:00 am to 2:00 pm. The clinic will close for lunch from 12:30 pm to 1:00 pm.

Towns County

Moved back to the health department, 1104 Jack Dayton Cir., Hiawassee on April 19. Vaccination are being administered on Wednesday only. Walk-ins will be accepted from 10:00 am to 2:00 pm. The clinic will close for lunch from 12:30 pm to 1:00 pm.

Banks County

Will remain at Grove Level Church, 1702 Grove Level Rd, Maysville. However, beginning May 10, the clinic will only operate on Monday, Tuesday, and Thursday. Walk-in will be accepted from 10:00 am to 2:00 pm. The clinic will close from 12:30 pm to 1:00 pm for lunch.

Franklin County

Will remain at the Franklin County Recreation Center, 557 Rocky Ford Rd., Carnesville. Beginning May 3, the clinic will only operate on Monday and Tuesday. Walk-ins will be accepted from 10:00 am to 2:00 pm. The clinic will close for lunch from 12:30 pm to 1:00 pm.

Habersham County

Will remain at Ruby Fulbright Center, 120 Paul Franklin Rd, Clarkesville through May 7. Beginning May 3, the clinic will operate only on Monday and Thursday. Then, on May 10, the clinic will move back to the health department at 185 Scoggins Dr., Demorest. After the move to the health department, the clinic will operate on Wednesday only. Walk-ins will be accepted from 10:00 am to 2:00 pm. The clinic will close for lunch from 12:30 pm to 1:00 pm.

Hart County

Will remain at Flat Shoals Church, 2999 Bowersville Hwy, Bowersville. Beginning May 3, the clinic will operate only on Tuesday, Thursday, and Friday. Walk-ins will be accepted from 10:00 am to 2:00 pm. on Tuesday and Thursday and on Friday from 9:00 am to 10:00 am. The clinic will close for lunch from 12:30 pm to 1:00 pm. On Friday, the clinic will close at 12:00 pm.

Rabun County

Moved back to the health department (upper level), 184 S. Main St., Clayton on April 19. Vaccinations are available on Tuesday and Thursday. Walk-ins will be accepted from 10:00 am to 2:00 pm. The clinic will close for lunch from 12:30 pm to 1:00 pm.

Stephens County

Stephens County will continue at St. Matthias Church, 995 E. Tugalo St., Toccoa. Beginning May 3, vaccination will be available on Tuesday and Thursday only. Walk-ins will be accepted from 10:00 am to 2:00 pm. The clinic will close for lunch from 12:30 pm to 1:00 pm.

White County

Will move back to the health department, 1331 Helen Hwy, Cleveland, on May 3. Vaccinations will then be available on Tuesday only. Walk-ins will be accepted from 10:00 am to 2:00 pm. The clinic will close for lunch from 12:30 pm to 1:00 pm.

Appointments are still recommended and can be made by calling 1-888-426-5073 or online at https://gta-vras.powerappsportals.us

No Change to vaccination schedules:

Dawson County         Veteran’s Park, 186 Recreation Drive, Dawsonville          Monday – Friday

Forsyth County          Cumming Fairground, 235 Castleberry Rd, Cumming       Monday – Friday

Hall County                UNG – Gainesville, 3280 Mundy Mill Rd., Oakwood           Monday – Friday

Lumpkin County        Senior Center, 266 Mechanicsville Rd., Dahlonega Monday – Friday

 

 

Georgia Expands COVID Vaccine Eligibility

News, Press Release

Atlanta – The Georgia Department of Public Health (DPH) and Governor Brian Kemp today announced the state will expand its vaccine eligibility March 15, 2021, to include adults aged 55 and older, individuals with disabilities, and certain medical conditions.

Individuals with intellectual and developmental disabilities are already eligible for vaccination. This expansion now includes disabilities caused by an injury (e.g., traumatic brain injury or spinal cord injury), a disability due to a longstanding condition that could cause vision loss, nerve damage or loss of a limb, or a disability due to illness such as ALS or multiple sclerosis.

The medical conditions referenced are:

  • Asthma
  • Cancer
  • Cerebrovascular disease
  • Chronic kidney disease
  • COPD
  • Cystic Fibrosis
  • Diabetes
  • Hypertension
  • Heart Conditions
  • Immunocompromised State
  • Liver Disease
  • Neurologic Conditions
  • Overweight and Obesity
  • Pregnancy
  • Pulmonary Fibrosis
  • Sickle Cell Disease
  • Thalassemia

To find a vaccine location near you or to schedule an appointment, log on to https://dph.georgia.gov/covid-vaccine. For individuals aged 16 and 17 who are in an eligible population for vaccination, Pfizer is the only vaccine currently approved for these ages. Please schedule an appointment at CVS or Walgreens or at one of the GEMA mass vaccination sites to ensure Pfizer vaccine is available to you.

For updates on COVID-19, follow @GaDPH and @GovKemp on Twitter and @GaDPH and @GovKemp on Facebook.

Union County hopes to vaccinate 1,000 in one day

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BLAIRSVILLE, Ga – Friday marked the first mass COVID-19 vaccination event for Union County, judging from the full schedule, one could label it a success.

The department of public health (DPH) controls who is eligible to receive the vaccine and individuals must sign up through the DPH website – more specifically the District 2 website. However, as of Thursday, the appointments were at full capacity and existing stock is committed as the second dose for other patients.

People arriving to receive their shot.

The state left it up to local health departments to administer the vaccines to people, which can be difficult in a small county. The people eligible to receive the vaccine greatly outnumber the nurses and DPH only allows a certain number of vaccines to each county. DPH is bringing on extra employees to help meet demand as well.

“They’re trying to do all the retirement villages, nursing homes, everything…most of our public safety personnel have already been given the opportunity to get their shot. Now that they’ve opened it up to 65 years and older, we’ve realized it’s going to take months and months to get these shots out at the rate they’re going,” Sole Commissioner Lamar Paris explained.

The COVID-19 vaccination set up inside the sports center. Photos courtesy of Union County EMA.

Fire Chief and EMA Director David Dyer and the local health department created the mass vaccination event at the new sports center.

“We’re experimenting with the logistics of making it all work,” Paris said. “We’ll have six or eight more that are going to be certified [to give shots.]”

The mass vaccination began at 8 a.m. and lasted until 8 p.m. 50 volunteers participated to help make the event a success.

“We can’t tell you when you’re going to be able to get the shot. We’re just going to the Gainesville office and saying give us as many shots as you can.”

The county has set up a link on their website to schedule an appointment for the vaccination event. They started with 150 shots on Monday and grew to 1,000 shots by Thursday.

“The way COVID-19 is spreading throughout the county…There’s no rhyme or reason to who gets it and who doesn’t,” Paris added, “It’s a serious thing, and we take it serious here at the county.”

Union County hopes to hold more mass vaccination events in the future for residents who want the shot – potentially for four consecutive weeks. However, continued vaccination events depend upon DPH sending additional medicine.

The rotary club, county employees, recreation department staff, EMA, and local health department staff all played vital roles in hosting the clinic.

Department of Public Health began to administer COVID-19 vaccine Monday

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HALL COUNTY, Ga. – Georgia received its first shipment of the COVID-19 vaccine last week. On Monday Georgia Department of Public Health (DPH) District 2 began to administer the vaccine to first responders in the community.

DPH Public Information Officer Dave Palmer said 35 firefighters, EMTs and other first responders were signed up to be among the first to receive the vaccine.

Nicholas Gallo who works with Georgia MedPort Ambulance Service said he was a little concerned about being among the first to get the vaccine. “New things are scary,” he said. “But I would rather not get sick.”

Palmer said, “Healthcare workers will be the next to receive the vaccine. We will administer those at the District Office at 1290 Athens Street.”

Most said the shots did not hurt and expressed confidence they would have a beneficial impact on the community. The vaccine comes in two doses. Those who received the vaccine today will have a second dose in about three weeks.

(Photo courtesy of Dave Palmer, Department of Public Health) Nicholas Gallo, and EMT with Georgia MedPort Ambulance Service was among the first to receive the vaccine on Monday.

 

Fetch Your News is a hyper local news outlet that covers Dawson, Lumpkin, White, Fannin, Gilmer, Pickens, Union, Towns and Murray counties as well as Cherokee County in N.C. FYN attracts 300,000+ page views per month, 3.5 million impressions per month and approximately 15,000 viewers per week on FYNTV.com and up to 60,000 Facebook page reach. If you would like to follow up-to-date local events in any of those counties, please visit us at FetchYourNews.com

 

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